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Clinical Trials/NCT02257749
NCT02257749
Terminated
N/A

Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.

Holland Bloorview Kids Rehabilitation Hospital1 site in 1 country1 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Concussion
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Enrollment
1
Locations
1
Primary Endpoint
Post Concussion Symptoms
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

Detailed Description

There is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. There is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. There is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. However, this approach to rehabilitation has yet to be explored using a randomized control trial protocol. Therefore, this study aims to answer the following question: Is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms? We hypothesize: 1. youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention. 2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • confirmed diagnosis of concussion
  • have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
  • are at least 4 weeks post injury
  • between the ages of 10 and 18 years
  • ability to speak English
  • ability to demonstrate capacity to consent to study

Exclusion Criteria

  • prior moderate or severe brain injury
  • neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
  • participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study

Outcomes

Primary Outcomes

Post Concussion Symptoms

Time Frame: Week 6 (upon completion of intervention)

The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.

Post-Concussion Symptoms

Time Frame: Week 0 (Baseline)

The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.

Secondary Outcomes

  • Quality of Life Level(Week 6 (upon completion of the intervention))
  • Balance(Week 6 (upon completion of intervention))
  • Mood(Week 6 (upon completion of the intervention))
  • Behavior(Week 6 (upon completion of the intervention))
  • Energy Level(Week 6 (upon completion of the intervention))
  • SCAT Balance(Week 0 (Baseline))
  • Satisfaction Level(Week 6 (upon completion of the intervention))
  • Anxiety(Week 6 (upon completion of the intervention))
  • Neurocognitive(Week 6 (upon completion of the intervention))
  • Activity Participation(Week 2)
  • Acute Concussion Evaluation(Week 0 (Baseline))
  • Occupational Performance(Week 6 (upon completion of the intervention))

Study Sites (1)

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